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Monitoring Neonatal Resuscitation Trial (MONITOR)

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ClinicalTrials.gov Identifier: NCT03256578
Recruitment Status : Active, not recruiting
First Posted : August 22, 2017
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
Leiden University Medical Center
Royal Women’s Hospital in Melbourne, Australia
Maternal & Children’s University Hospital, Valencia, Spain
Vittore Buzzi Children's Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Elizabeth Foglia, University of Pennsylvania

Brief Summary:
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.

Condition or disease Intervention/treatment Phase
Resuscitation Neonatal Prematurity Positive-Pressure Respiration Device: New Life Box Respiratory Function Monitor Not Applicable

Detailed Description:

Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.

The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.

The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.

The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.
Masking: Single (Outcomes Assessor)
Masking Description: The waveform data and videos captured during the study intervention will be centralized to Leiden University Medical Center. The team at Leiden University Medical Center assessing the outcomes will be will be blinded to the randomization allocation of the infant.
Primary Purpose: Health Services Research
Official Title: A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : May 17, 2019
Estimated Study Completion Date : September 20, 2021

Arm Intervention/treatment
Experimental: RFM visible
During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.
Device: New Life Box Respiratory Function Monitor
The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.

No Intervention: RFM masked
During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.



Primary Outcome Measures :
  1. Positive-Pressure Ventilation proportions between 4 - 8 mls/kg [ Time Frame: for the first 15 minutes of resuscitation ]
    To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.


Secondary Outcome Measures :
  1. Oximetry data on SpO2 and heart rate from Respiratory Function Monitor [ Time Frame: approximately first 10 minutes of life ]
    Oximetry data on SpO2 and heart rate from Respiratory Function Monitor

  2. Significant mask leak >60% [ Time Frame: proportion of PPV in approximately first 15 minutes of resuscitation ]
    Duration of significant mask leak (defined as > 60 %) as a proportion of time face mask was used for PPV

  3. Significant airway obstruction [ Time Frame: proportion of PPV in approximately first 15 minutes of resuscitation ]
    Defined as a reduction in flow and volume (< 25th percentile of measured VTe with minimal leak during the inflation and typical flattening of the flow waves and the PIP was unchanged) as a proportion of the time face mask is used for PPV.

  4. Occurrence of inadequate tidal volume [ Time Frame: proportion of PPV in approximately first 15 minutes of resuscitation ]
    defined as <4 ml/kg

  5. Oxygen saturation (SpO2) levels [ Time Frame: Between 3 and 10 minutes of resuscitation ]
    Oxygen saturation (SpO2) levels

  6. FiO2 changes [ Time Frame: in first 10 minutes of resuscitation ]
    FiO2 changes

  7. duration 100% oxygen delivered [ Time Frame: in first 10 minutes of resuscitation ]
    Total amount of pure oxygen given to the patient (oxygen load) in first 10 minutes will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.

  8. Rates of endotracheal intubation [ Time Frame: in first 24 hours after birth ]
    Rates of endotracheal intubation

  9. need for circulatory support [ Time Frame: in first 24 hours after birth ]
    The need for circulatory support (inotropes and fluid boluses)

  10. incidence of air leak [ Time Frame: in the first 72 hours after birth ]
    Incidence of air leak (pneumothorax, pulmonary interstitial emphysema, or pneumomediastinum) reported by a radiologist masked to the intervention.

  11. Incidence of abnormal cranial ultrasound findings [ Time Frame: through study completion, an average of 4 months ]
    Incidence of abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia

  12. Duration of endotracheal ventilation [ Time Frame: through study completion, an average of 4 months ]
    Duration of endotracheal (ET) ventilation (hours)

  13. Duration of nasal CPAP [ Time Frame: through study completion, an average of 4 months ]
    Duration of nasal CPAP (hours)

  14. Duration of supplemental oxygen therapy [ Time Frame: through study completion, an average of 4 months ]
    Duration of supplemental oxygen therapy (hours)

  15. Total duration of assisted ventilation [ Time Frame: through study completion, an average of 4 months ]
    Total duration of assisted ventilation (ET, CPAP) in hours

  16. Incidence of bronchopulmonary dysplasia [ Time Frame: at 36 weeks corrected gestational age ]
    Incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support

  17. Neonatal mortality [ Time Frame: within a week after birth and before discharge from hospital ]
    Neonatal mortality

  18. Composite outcome of death or BPD [ Time Frame: through study completion, an average of 4 months ]
    Composite outcome of death or BPD

  19. Retinopathy of prematurity needing treatment [ Time Frame: through study completion, an average of 4 months ]
    Retinopathy of prematurity needing treatment

  20. Incidence of Necrotizing enterocolitis [ Time Frame: through study completion, an average of 4 months ]
    Incidence of Necrotizing enterocolitis grade 2 or more



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
  • Receive positive pressure ventilation during delivery room resuscitation

Exclusion Criteria:

  • Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
  • RFM not available during resuscitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256578


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Leiden University Medical Center
Royal Women’s Hospital in Melbourne, Australia
Maternal & Children’s University Hospital, Valencia, Spain
Vittore Buzzi Children's Hospital
Karolinska University Hospital
Investigators
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Principal Investigator: Arjan te Pas, MD Leiden University Medical Center

Publications:
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Responsible Party: Elizabeth Foglia, Assistant Professor of Pediatrics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03256578     History of Changes
Other Study ID Numbers: 826695
NTR4104 ( Registry Identifier: Netherlands Trial Registry )
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elizabeth Foglia, University of Pennsylvania:
Resuscitation
Neonatal Prematurity
Positive-Pressure Ventilation
Respiratory Function Monitor
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications